Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

fresenius kabi ab - vítamín a (palmítat); vítamín e (tocoferolum nfn); phytomenadionum inn; ergocalciferolum inn - innrennslisþykkni, fleyti

Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

mundipharma a/s - buprenorphinum inn - forðaplástur - 10 míkróg/klst.

Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

mundipharma a/s - buprenorphinum inn - forðaplástur - 20 míkróg/klst.

Исланд - Исландски - LYFJASTOFNUN (Icelandic Medicines Agency)

mundipharma a/s - buprenorphinum inn - forðaplástur - 5 míkróg/klst.

Европска Унија - Исландски - EMA (European Medicines Agency)

bial - portela & ca, s.a. - eslikarbazepín asetat - flogaveiki - antiepileptics, - zebinix er ætlað sem viðbótarmeðferð hjá fullorðnum, unglingum og börnum eldri en 6 ára, með flogaveiki með eða án aukakvilla.

Европска Унија - Исландски - EMA (European Medicines Agency)

bristol-myers squibb pharma eeig - nivolumab - melanoma; hodgkin disease; carcinoma, renal cell; carcinoma, non-small-cell lung; carcinoma, transitional cell; squamous cell carcinoma of head and neck; urologic neoplasms; mesothelioma; colorectal neoplasms - Æxlishemjandi lyf - melanomaopdivo as monotherapy or in combination with ipilimumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older. relative to nivolumab monotherapy, an increase in progression free survival (pfs) and overall survival (os) for the combination of nivolumab with ipilimumab is established only in patients with low tumour pd-l1 expression. adjuvant treatment of melanomaopdivo as monotherapy is indicated for the adjuvant treatment of adults and adolescents 12 years of age and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. non-small cell lung cancer (nsclc)opdivo in combination with ipilimumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising egfr mutation or alk translocation. opdivo as monotherapy is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. malignant pleural mesothelioma (mpm)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. neoadjuvant treatment of nsclcopdivo in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have pd-l1 expression ≥ 1%. renal cell carcinoma (rcc)opdivo as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults. opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor risk advanced renal cell carcinoma. opdivo in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma. classical hodgkin lymphoma (chl)opdivo as monotherapy is indicated for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant (asct) and treatment with brentuximab vedotin. squamous cell cancer of the head and neck (scchn)opdivo as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy. urothelial carcinomaopdivo as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum containing therapy. adjuvant treatment of urothelial carcinomaopdivo as monotherapy is indicated for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (miuc) with tumour cell pd-l1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of miuc. mismatch repair deficient (dmmr) or microsatellite instability-high (msi-h) colorectal cancer (crc)opdivo in combination with ipilimumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy. oesophageal squamous cell carcinoma (oscc)opdivo in combination with ipilimumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell pd-l1 expression ≥ 1%. opdivo as monotherapy is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based combination chemotherapy. adjuvant treatment of oesophageal or gastro-oesophageal junction cancer (oc or gejc)opdivo as monotherapy is indicated for the adjuvant treatment of adult patients with oesophageal or gastro-oesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. gastric, gastro‑oesophageal junction (gej) or oesophageal adenocarcinomaopdivo in combination with fluoropyrimidine- and platinum-based combination chemotherapy is indicated for the first‑line treatment of adult patients with her2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express pd-l1 with a combined positive score (cps) ≥ 5.

Европска Унија - Исландски - EMA (European Medicines Agency)

era consulting gmbh - pegfilgrastim - daufkyrningafæð - Ónæmisörvandi, , nýlendan að örva þáttum - lækkun á lengd mæði í tengslum og tíðni hita og mæði í tengslum í fullorðinn sjúklinga með frumudrepandi lyfjameðferð fyrir illkynja (með undantekning langvarandi merg hvítblæði og myelodysplastic heilkennum).

Европска Унија - Исландски - EMA (European Medicines Agency)

novartis europharm limited - ruxolitinib (sem fosfat) - myeloproliferative disorders; polycythemia vera; graft vs host disease - Æxlishemjandi lyf - myelofibrosis (mf)jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. polycythaemia vera (Úsbekistan)ráðlagt er ætlað fyrir meðferð fullorðinn sjúklinga með polycythaemia vera sem eru ónæmir fyrir eða þola hýdroxýúrea. graft versus host disease (gvhd)jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5.

Европска Унија - Исландски - EMA (European Medicines Agency)

stemline therapeutics b.v. - elacestrant - brjóstakrabbamein - innkirtla meðferð - orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (er) positive, her2-negative, locally advanced or metastatic breast cancer with an activating esr1 mutation who have disease progression following at least one line of endocrine therapy including a cdk 4/6 inhibitor.

Европска Унија - Исландски - EMA (European Medicines Agency)

janssen-cilag international nv - samanburður - psoriasis; arthritis, psoriatic; crohn disease; colitis, ulcerative - Ónæmisbælandi lyf - crohn-diseasestelara er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka crohn-sjúkdóm sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða tnfa hemla eða hafa læknis frábendingar til slíkra meðferða. sárum colitisstelara er ætlað fyrir meðferð fullorðinn sjúklinga með nokkuð að alvarlega virka sárum niðurgang sem hafa verið ófullnægjandi að bregðast við, misst að bregðast við, eða voru óþol að annaðhvort hefðbundin meðferð eða líffræðileg eða hafa læknis frábendingar til slíkra meðferða. sýklum psoriasisstelara er ætlað fyrir meðferð í meðallagi til alvarlega sýklum psoriasis í fullorðnir sem tókst ekki að bregðast við, eða sem hafa frábending, eða þola öðrum almenn meðferð þar á meðal ciclosporin, stendur og psoralen útfjólubláum a. börn sýklum psoriasisstelara er ætlað fyrir meðferð í meðallagi til alvarlega sýklum psoriasis í börn og unglingur sjúklingar frá 6 ára og eldri, sem eru ekki nægilega stjórnað af, eða eru þola, hinn almenna meðferð eða phototherapies. psoriasis arthritisstelara, einn eða ásamt stendur, er ætlað fyrir meðferð virk psoriasis liðagigt í fullorðinn sjúklinga þegar svar til fyrri ekki líffræðileg sjúkdómur-að breyta verkjalyf eiturlyf (dmard) meðferð hefur verið ófullnægjandi.